NCT05426109

Brief Summary

Many athletes and military personnel desire weight gain primarily as lean mass to improve performance and effectiveness in military/sport endeavors. While much is known about the energy restriction required to reduce body weight, very little is understood about energy and macronutrients needed to promote healthy gains in body weight and lean mass. Typically, athletes are encouraged to increase calorie intake by \~500 kcal/day with an emphasis on adequate protein and carbohydrate, and judicious inclusion of healthy fat-containing calorically-dense foods, including peanuts and peanut butter. This study proposes to evaluate the effect of a 10-week diet and exercise regimen designed to promote healthy weight gain. This will include increasing energy intake by 500 additional kcal/day (above weight maintenance diet) through daily provision of either peanut-based whole foods/snacks (peanut group) or a similar, high-carbohydrate, peanut-free snack (control group) along with a supervised strength training regimen. Results will serve as an important first step in helping understand the gaps in knowledge related to healthy weight gain, designing better weight gain meal plans, not only in athletes and military personnel, but also in clinical populations where promotion of weight gain is advocated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 22, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2024

Completed
7 months until next milestone

Results Posted

Study results publicly available

June 10, 2025

Completed
Last Updated

June 10, 2025

Status Verified

May 1, 2025

Enrollment Period

12 months

First QC Date

June 15, 2022

Results QC Date

January 24, 2025

Last Update Submit

May 21, 2025

Conditions

Keywords

Hypercaloric dietWeight trainingLean massBody composition

Outcome Measures

Primary Outcomes (2)

  • Change in Total Body Mass (Weight)

    Participants will be weighed on a digital scale wearing standardized lab clothes at all scheduled testing sessions throughout the study.

    1-min laboratory measurement assessed at the baseline, 3-wk, 7-wk, and 11-week test sessions.

  • Change in Lean Body Mass

    Participants will undergo a dual-energy x-ray absorptiometry scan wearing standardized lab clothing at all scheduled testing sessions throughout the study. The scan analysis provides body composition results, including lean (fat-free) mass (kg).

    10-min laboratory measurement assessed at the baseline, 3-wk, 7-wk and 11-week test sessions.

Secondary Outcomes (3)

  • Change in Resting Metabolic Rate

    60-min laboratory measurement assessed at the baseline, 3-week, and 11-week test sessions.

  • Change in Testosterone Levels

    5-min laboratory measurement assessed at the baseline, 3-week, 7-week, and 11-week test sessions.

  • Change in Insulin-Like Growth Factor Levels

    5-min laboratory measurement assessed at the baseline, 3-week, 7-week, and 11-week test sessions.

Study Arms (2)

Peanut snacks

EXPERIMENTAL

Participants will be provided and consume an extra 500 kcal/day of peanut-containing snacks for 10 weeks.

Other: Peanut snacks

No peanut-containing snacks

ACTIVE COMPARATOR

Participants will be provided and consume an extra 500 kcal/day of snacks without peanuts or peanut-containing foods for 10 weeks.

Other: No peanut-containing snacks

Interventions

Participants will undergo a 10-week diet and weight training regimen to promote healthy weight gain. These participants will receive seven 500 kcal peanut-containing (whole peanuts or peanut butter) snacks each week and consume one snack per day throughout the study. They will also perform a series of weight training exercises supervised by a personal trainer on 3 days per week.

Peanut snacks

Participants will undergo a 10-week diet and weight training regimen to promote healthy weight gain. These participants will receive seven 500 kcal non-peanut-containing high carbohydrate snacks each week and consume one snack per day throughout the study. They will also perform a series of weight training exercises supervised by a personal trainer on 3 days per week.

No peanut-containing snacks

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Interested in gaining 5 pounds of body weight to enhance effectiveness in sport, fitness, or military training/competition.
  • Willing to eat 500 kcal/d and weight train 3x/wk for 10 weeks
  • Have weight trained in the past 12 months
  • Not taking medications or dietary supplements that influence study results
  • Non-smoker
  • Without any major medical problems (including high blood pressure or coronary heart disease)

You may not qualify if:

  • Nut, peanut, tree nut or legume allergy
  • No weight training experience
  • Orthopedic limitations that affect ability to weight train
  • Currently taking dietary supplements or prescribed pharmacological agents that may affect lean tissue accretion
  • Current or past anabolic steroid use
  • Have a history of or current signs of disordered eating
  • Pregnant
  • Abnormal levels of thyroid stimulating hormone or hemoglobin, serum lipids (e.g., fasting triglycerides \>150 mg/dL and/or total cholesterol \>200 mg/dL)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Polytechnic Institute and State University

Blacksburg, Virginia, 24061, United States

Location

Related Publications (1)

  • Sanchez AD, Reynolds JC, Marinik EL, Kolb RD, Lozano AJ, Davy BM, Hunter GR, Larson-Meyer DE. A Randomized Trial of Healthy Weight Gain in Athletic Individuals. Med Sci Sports Exerc. 2024 Aug 1;56(8):1454-1466. doi: 10.1249/MSS.0000000000003427. Epub 2024 Mar 23.

MeSH Terms

Conditions

Weight Gain

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Larson-Meyer
Organization
Virginia Tech

Study Officials

  • Enette Larson-Meyer, PhD

    Virginia Polytechnic Institute and State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Both the investigators and participants are aware of the group assignment since the foods prepared and provided (peanut-containing or no peanut snacks) cannot be masked.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 15, 2022

First Posted

June 21, 2022

Study Start

November 22, 2021

Primary Completion

November 10, 2022

Study Completion

November 12, 2024

Last Updated

June 10, 2025

Results First Posted

June 10, 2025

Record last verified: 2025-05

Locations